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triFX GEN 36L

by Pollogen Ltd

Ref 30010160BK

triFX GEN 36L is a device classified as Class IIa in the EU and Class II in the US made by Pollogen Ltd, registered in EUDAMED on 4 Aug 2026 (Basic UDI-DI B-17290016586500), cleared under FDA 510(k) K173503 on 11 Jun 2018 and listed in FDA GUDID since 30 May 2022 (UDI-DI 17290016586500), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K173503

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-17290016586500 Basic UDI-DI 17290016586500UDI-DIDate4 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number17290016586500 UDI-DI Date30 May 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK173503 Date11 Jun 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-17290016586500 registered 4 Aug 2026 Active
  • FDA 510(k) K173503 decided 11 Jun 2018 Active
  • FDA GUDID UDI-DI 17290016586500 listed 30 May 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K173503
  2. Listed FDA GUDID 17290016586500
  3. Registered EUDAMED B-17290016586500

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
triFX
Generic name
Radio-frequency skin contouring system applicator tip
Device name
gen 36L
Model / reference
30010160BK EUDAMED
GEN 36L GUDID
Description
triFX 36L TIP ASSY 5 PACK (old name: GEN 36L DISPOSABLE TIP ASSY 5 PACKED BK)
Primary DI / UDI-DI
17290016586500
Basic UDI-DI
B-17290016586500
FDA product code
GEI
EMDN code
Z12040285 General medicine therapeutic treatment instruments - consumables
GMDN term
Radio-frequency skin contouring system applicator tip
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
878.4400
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
30010160BK
GUDID
GEN 36L
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Radio-frequency skin contouring system applicator tip

Cleared under the same submission (K173503)

and 8 more cleared under K173503

Similar devices in this category

Other devices filed under GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS.

Other devices from Pollogen Ltd

See all devices from Pollogen Ltd →

Properties

  • Supplied sterile
  • Single use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)